ISPE and PDA to host scientific conferences on ICH Q8 and Q9

April 24, 2006 — /ISPE/ — TAMPA, Fla. — The International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA®) today announced an agreement to host two scientific training conferences addressing the International Conference on Harmonisation’s (ICH) Q8 and Q9 pharmaceutical development and quality risk management guidance. ISPE and PDA, both global leaders supporting the pharmaceutical industry, hope this partnership is representative of future combined efforts between the two organizations.

Scheduled for December 4-5, 2006 in Washington, D.C. and February 2007 in Brussels, Belgium, the events will be themed, “Challenges of Implementing Q8 and Q9 ? Practical Application.” Industry leaders and regulatory authority representatives will examine the current and future needs for a long-term vision for Q8 and Q9 implementation.

“I am pleased we are able to join forces with PDA to produce these important events,” says President and CEO of ISPE, Bob Best. “By combining our expertise on these subjects we will be able to better serve the industry. I would also like to thank two of the ICH members, the US FDA and PhRMA, for their assistance on the program content.”

The conferences will particularly benefit executives, managers and scientists working in quality assurance, quality control, manufacturing, regulatory affairs, drug development, compliance, validation and R&D. Attendees will learn how to apply the Q8 and Q9 guidances into their company’s manufacturing and R&D processes. The take home specific strategies attendees will learn to identify will aid in mitigating risks associated with pharmaceutical manufacturing and development.

“We are excited about the opportunity to work with ISPE on this initiative,” said Robert Myers, PDA President. “These conferences will enable both organizations to leverage our strengths to provide high-level scientific forums that will be mutually beneficial to our members and the pharmaceutical and biopharmaceutical community.”

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ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for over 23,000 pharmaceutical manufacturing professionals in 80 countries. ISPE aims to be the catalyst for “Engineering Pharmaceutical Innovation” by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida, Brussels, Belgium, and an office in Singapore to serve Asia-Pacific. Visit www.ispe.org for additional Society news and information.

About PDA Connecting People, Science and Regulation

The Parenteral Drug Association (PDA) is a nonprofit international organization and a leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 10,000 members worldwide. More information about PDA is available at www.pda.org.

For more information contact:
Valerie Kestner
ISPE Public Relations Manager
+1-813-960-2105 x 277
[email protected]
PDA
Contact: Matthew Clark
[email protected]
Tel: +1 (301) 656-5900, ext. 125

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